Experience

Pyramid Biosciences

• Biotechnology Research
• 1 - 100 Employee

• Clinical Operations Executuve Consultant

  • Feb 2023 - Present



Eidos Therapeutics

• United States
• Biotechnology
• 1 - 100 Employee

• Relationship Site Manager/Clinical Operations Consultant

  • May 2019 - Present



Clinical Research Consulting Ltd

• County Dublin, Ireland

• CEO

  • Oct 2018 - Present

  Clinical Research Consulting Ltd: Owner Clinical Research Consulting Ltd: Owner



Nektar Therapeutics

• Biotechnology
• 300 - 400 Employee

• Clinical Operations Consultant/Global Start Up Lead

  • Oct 2018 - Jun 2020

  Clinical Operations Clinical Operations



Prothena Corporation

• Ireland
• Biotechnology Research
• 1 - 100 Employee

• European Head Clinical Operations/Senior Director

  • May 2015 - Dec 2018

  Leadership & strategic oversight of clinical trial execution Apply KPIs to ensure successful execution of clinical trials to agreed timelines Ensure quality, timely, resources & budget goals met Resourcing (Dept & Trials), built EU clinical operations team Selection & management of clinical & non- clinical CROs Vendor selection & management Provide Strategic guidance to senior management on process development & organisation structure Investigator meeting organisation & management Lead cross functional teams in developing a Phase IIb study design in AL Amyloidosis & a Phase I study design for ATTR Amyloidosis & ensured timely submission to multiple EU Competent Authorities, Ethics committees/ US IRB ‘s Successful initiation of studies across approx. 50 sites/15 countries Liaise with program project teams ensuring alignment of program goals Communicate key study updates to Leadership team, R&D team, Project Team Study Management Team Lead Review & provide clinical input for international Regulatory submissions including Scientific Advice packages & Development of Risk Management Plans Close collaboration with Commercial/Marketing/Medical Affairs teams to ensure market readiness Coordinated, managed, & lead Advisory Board Meetings in ATTR Amyloidosis Developed Investigator Sponsored trial, (IST) SOPs & contracts Built strong lasting relationships with KOLs, research collaborators & patient advocacy groups Submission readiness activities e.g., Pre-Approval Inspection/assigned to PAI team Keeping abreast of industry innovations, therapeutic training by attending conferences, reading publications& interacting with KOLs Liaise with QA & other functions to ensure clinical trial execution to the highest quality standards per clinical development plans & timelines Develop & maintain strong relationships with CROs, vendors, Coordinate with Biometrics to deliver high quality data deliverables on time /budget



Aspen Pharma Australia

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Head of Clinical Operations

  • Sep 2014 - May 2015

  •Responsible for the planning and execution of clinical studies in regions and, in collaboration with other development functions, for the analysis, reporting and publication of related scientific medical data •Management of outsourced partners and all clinical activities in regions in line with the company strategic plans, performed according to the highest GCP and Aspen quality standards, and in compliance with local regulatory requirements •Project management of contractual and financial aspects of all clinical trial projects and the effective utilisation of resources to keep processes cost effective •Lead planning and implementation of clinical studies assigned to region •Management/ Supervision of CRO’s •Ensure preparation of all clinical aspects of internal and regulatory audits and inspections in region •Ensure continued education and compliance of team in region with external regulatory requirements and internal policies, as well as up-to-date expertise in relevant operational, clinical, epidemiological, pharmaco-economical, evidence-basis and other scientific aspects of products •Provide input on global and regional medical and regulatory needs in order to ensure that the medical regional perspective is taken into consideration in shaping global clinical and regulatory plans •Development of good working relationships with internal and external stakeholders



Daiichi Sankyo Ireland Ltd.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Liaison Manager

  • Nov 2013 - Jul 2014

  Establishment and building of strong working relationships, facilitating a mutually beneficial two-way exchange on products, disease area & wider specialist medical arena with all (KOLs) &(OLs) within the commercial operating environment & Irish healthcare system Dissemination of medical and clinical information on all products with particular emphasis on market preparation initiatives pre, during & post launch of new products Responsible for Pharmacovigilance, Medical Affairs & Quality Management activities Relationship building with Thought Leaders, in accordance with the strategy developed by the Company to gain insight into treatment patterns, the scientific activities taking place within the Disease Area & the needs of health care providers in the Disease Area Respond appropriately with accurate scientific data to unsolicited scientific questions from Physicians for Products/Brands with a Marketing Authorisation (on & off label) &for products in development in compliance with Company Policies, and legal and ethical standards Deliver clinical data in support of health economic/value proposition discussions with payors e.g., advanced budgetary notification Contribute to development of Brand Plans & Strategies by communicating KOL insight about the disease area, unmet medical needs & treatment patterns Develop & contribute to scientific presentations Advisory Board Management & Co-ordination



Cancer Trials Ireland

• Ireland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clincial Project Manager

  • Jan 2002 - Oct 2013

  I am an accomplished clinical project manager in the oncology arena and am responsible for the project management of oncology clinical trials primarily in breast cancer within ICORG, the All Ireland Cooperative Oncology Research Group. I hold an MSc in Oncology from the University of Nottingham, UK. With more than 18 years cancer clinical research experience, I have worked in ICORG for 11 years having also previously worked in CRO and pharmaceutical settings. I also write a quarterly oncology article for an Irish cancer magazine ’Cancer Professional’ and have presented at translational research and clinical conferences.